Combination Chemotherapy With or Without Ganitumab in Treating Patients With Previously Untreated Metastatic Pancreatic Cancer

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT01473303
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ganitumab — BIOLOGICAL
    Given IV
  • fluorouracil — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • leucovorin calcium — DRUG
    Given IV
  • oxaliplatin — DRUG
    Given IV
  • placebo — OTHER
    Given IV
  • questionnaire administration — OTHER
    Completed on paper

Study Details

RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin calcium, irinotecan hydrochloride, and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as ganitumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry cancer-killing substances to them. It is not yet known whether giving more than one drug (combination chemotherapy) is more effective with or without ganitumab in treating patients with pancreatic cancer. PURPOSE: This phase I/II trial is studying the best dose of combination chemotherapy and ganitumab and how well combination chemotherapy with or without ganitumab works in treating patients with previously untreated metastatic pancreatic cancer.

Key Dates

Start date
Aug 31, 2012
Status verified
Jun 2016
Primary completion
Aug 31, 2012

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I
    Patients receive oxaliplatin IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and leucovorin calcium IV over 2 hours on day 1 and fluorouracil IV over 48 hours beginning on day 2 (mFOLFIRINOX) and ganitumab IV over 30-60 minutes on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II
    Patients receive mFOLFIRINOX as in arm I and placebo IV over 30-60 minutes on day 1.

Primary Outcome Measure

Dose-limiting toxicity (phase I)

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